Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
NCT ID:
NCT03765918
Pre Assignment Details:
Two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations). One of the participants (who received one cycle of neoadjuvant treatment) was included in the SOC arm for the efficacy and safety analyses per protocol. The other participant (who received 2 cycles of neoadjuvant treatment) was included in the SOC arm for efficacy analysis and in the Pembrolizumab + SOC arm for the safety analysis per protocol.
Recruitment Details:
Per protocol, patient-reported outcome (PRO) measures (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 \[EORTC QLQ-C30\] Global Health Status \[GHS\]/Quality of Life \[QoL\]\[Items 29 and 30\], EORTC QLQ-C30 \[Items 1-5\], EORTC QLQ-Head and Neck Module 35 \[H\&N35\] \[Items 35-38\], EORTC QLQ-H\&N35 \[Items 46, 53-54\], and EORTC QLQ-H\&N35 \[Items 31-34\] were reported separately for neoadjuvant and adjuvant treatment periods.
Study:
NCT03765918
Study Brief:
Results Section:
NCT03765918